The following article is a part of conference coverage from the American Academy of Allergy, Asthma & Immunology Annual Meeting, being held in Phoenix, Arizona, from February 25 to 28, 2022. Click here to read more of MPR‘s conference coverage.

Patients with a history of asthma exacerbations in the previous year and elevated type 2 (T2) biomarkers who were treated with the monoclonal antibody lebrikizumab (LEB) exhibited a significant reduction in exacerbations. These were among the findings of a post-hoc analysis of the duplicate placebo-controlled, phase 3 LAVOLTA I and LAVOLTA II trials of patients with moderate to severe asthma. Results of the analysis are being presented at the American Association of Allergy, Asthma & Immunology (AAAAI) 2022 Annual Meeting, held in Phoenix, Arizona, from February 25 to 28.

LAVOLTA I and LAVOLTA II enrolled patients regardless of their asthma exacerbation history, baseline blood eosinophila, or fractional exhaled nitric oxide (FeNO) level, with 2 dose groups evaluated: LEB 125mg every 4 weeks or LEB 37.5mg every 4 weeks. The primary study endpoint was the adjusted exacerbation rate ratio (AERR) in T2-positive patients, which was defined as having periostin levels of at least 50 ng/mL or blood eosinophils (eos) of at least 300 cells/µL. Results of both LAVOLTA I and LAVOLTA II failed to demonstrate consistently significant results in AERR or a dose response.

The current post-hoc analysis established AERR for LEB vs placebo from the LAVOLTA I and LAVOLTA II trials in subpopulations of patients with at least 1 exacerbation in the previous 12 months. Patients were grouped and analyzed according to their baseline levels of FeNO (≤25 ppb, ≥25 to <50 ppb, or ≥50 ppb) and eosinophilia (eos <150 cells/µL, ≥150 to <300 cells/µL, or ≥300 cells/µL).

Results of the study showed that LEB reduced AERR vs placebo in combined LAVOLTA I and LAVOLTA II trials as follows: (1) FeNO 25 ppb or greater (LEB 125mg: 0.79; 95% CI, 0.62-1.01; LEB 37.5mg: 0.75; 95% CI, 0.58-0.96); (2) FeNO 25 or greater to less than 50 ppb (LEB 125mg: 0.83; 95% CI, 0.63-1.07; LEB 37.5mg: 0.70; 95% CI, 0.53 to 0.92); (3) FeNO 50 ppb or greater (LEB 125 mg: 0.55; 95% CI,0.41-0.72; LEB 37.5 mg: 0.53; 95% CI, 0.40 to 0.69); (4) eos <150 cells/µL (LEB 125mg: 0.94; 95% CI, 0.68-1.29; LEB 37.5mg: 0.57; 95% CI, 0.40-0.82); (5) eos 150 or greater to less than 300 cells/µL (LEB 125 mg: 0.75; 95% CI, 0.56-0.99); LEB 37.5mg: 0.76; 95% CI, 0.57-1.02), (6) eos 300 cells/µL or greater (LEB 125mg: 0.62; 95% CI, 0.50-0.76; LEB 37.5mg: 0.59; 95% CI, 0.48-0.73).

The investigators concluded that LAVOLTA study participants with a history of prior-year asthma exacerbations and elevated T2 biomarkers did experience significantly fewer exacerbations, and that future studies are needed with optimal targeting of LEB in patients with exacerbation-prone T2 inflammation.

Disclosure: None of the study authors has declared affiliations with biotech, pharmaceutical, and/or device companies.  

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Sher E, Korenblat P, Brusselle G, et al. Post-hoc analysis of lebrikizumab phase 3 trials (LAVOLTA  I and II): enhanced efficacy in patients  with prior exacerbations and elevated baseline FENO or blood eosinophilia. Presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) 2022 Annual Meeting; February 25–28, 2022; Phoenix, AZ. Abstract 191.                      

This article originally appeared on Pulmonology Advisor